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Showing 1151 - 1200Tafasitamab-cxix in the Treatment of Diffuse Large B-Cell Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 31, 2020, tafasitamab-cxix, a CD19-directed...
Switch Control Inhibitor for GISTs Harboring Drug-Resistance Mutations: The INVICTUS Trial
In May 2020, the U.S. Food and Drug Administration (FDA) approved ripretinib for patients who have received prior treatment with three or more kinase inhibitors, including imatinib, for advanced gastrointestinal stromal tumors (GIST). The approval was largely based on the findings of the...
Chemotherapy-Free Approaches in Follicular and Mantle Cell Lymphomas
As chemotherapy and chemoimmunotherapy regimens reach their maximal impact in follicular lymphoma and mantle cell lymphoma, clinicians are turning to chemotherapy-free approaches to achieve better control, less toxicity, and (hopefully) a cure. During the ASCO20 Virtual Education Program, Sonali M. ...
Past CMS and FDA Head Discusses Challenges in U.S. Health-Care Policy and Possible Solutions
As evidenced at this year’s ASCO20 Virtual Scientific Program, oncology science, technology, and clinical practice are evolving at a rapid pace, bringing new challenges to the efficient and ethical practice of cancer care at all levels. To shed light on some of the large-scale public health and...
FDA Approves Daratumumab Plus Carfilzomib and Dexamethasone for Relapsed or Refractory Multiple Myeloma
On August 20, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with carfilzomib (Kyprolis) and dexamethasone (DKd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy....
FDA Pipeline: Priority Reviews for Immunotherapy Dose Regimen, Small Cell Lung Cancer; Fast Track Designations in Brain Cancer and Leukemia
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for a novel dosing regimen for durvalumab as well as for trilaciclib in small cell lung cancer; granted Fast Track designations to treatments for glioblastoma and B-cell acute lymphoblastic leukemia; and issued reports...
Tumor Mutational Burden and the Future of Complex Biomarkers
The development of complex biomarkers such as tumor mutational burden (TMB) has enabled clinicians to identify patients more likely to respond to treatment of a variety of cancers, leading to more accurate diagnoses and improved outcomes. Differences in testing assays, however, have produced...
Balancing Efficacy and Safety of Targeted Therapy in Breast Cancer Care
Novel targeted therapies have increased the likelihood of cure and prolonged survival in many patients with advanced breast cancer (Table 1), but these new agents also carry toxicity profiles that vary greatly from those of traditional chemotherapy. During the ASCO20 Virtual Education Program,...
Expert Point of View: Amit Mahipal, MBBS, MPH
Amit Mahipal, MBBS, MPH, Consultant, Associate Professor of Oncology, Mayo College of Medicine, Rochester, put the findings for tremelimumab/durvalumab into context regarding other studies evaluating checkpoint inhibitors in advanced hepatocellular carcinoma. In the current study by Kelly et al, he ...
FDA Pipeline: Approval for First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic; Designations in Ovarian Cancer, Leukemia, and Lymphoma
Recently, the U.S. Food and Drug Administration (FDA) approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with non–small cell lung cancer (NSCLC) and specific types of EGFR mutations. The FDA also granted Fast Track...
Novel Indications and New Drugs for the Treatment of Bladder Cancer
Pembrolizumab: On January 8, 2020, pembrolizumab (Keytruda) was approved by the U.S. Food and Drug Administration (FDA) for bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or...
Study Supports Pembrolizumab Plus Axitinib in Previously Untreated Advanced Renal Cell Carcinoma
Extended analysis of the phase III KEYNOTE-426 study upholds pembrolizumab plus axitinib as a preferred front-line regimen over sunitinib in patients with advanced sporadic renal cell carcinoma.1 These updated results were presented during the ASCO20 Virtual Scientific Program by Elizabeth R....
Nonmetastatic Castration-Resistant Prostate Cancer
Nonmetastatic castration-resistant prostate cancer arises in the subset of men with biochemically recurrent disease (ie, rising prostate-specific antigen [PSA] level after definitive therapy in the absence of metastases) who develop PSA progression after chronic exposure to androgen-deprivation...
Novel Indications and New Drugs for Castration-Resistant or Castrate-Sensitive Prostate Cancer
The past year has witnessed the U.S. Food and Drug Administration (FDA) approval of a number of drugs for treatment of patients with metastatic castrate-resistant prostate cancer or castrate-sensitive prostate cancer. Castrate-Resistant Prostate Cancer Olaparib: On May 19, 2020, olaparib...
Final Analysis of the ARAMIS Trial in Men With Nonmetastatic Castration-Resistant Prostate Cancer
A year ago, initial results from the double-blind, multicenter, randomized phase III ARAMIS clinical trial evaluating the efficacy and safety of darolutamide, a structurally unique androgen-receptor antagonist, in men with nonmetastatic castration-resistant prostate cancer, were published in The...
Genitourinary Oncology Highlights 2019–2020 Almanac
Over the past year, we have seen significant advances in the treatment of prostate, kidney, and urothelial cancers that will benefit patients now and in the future. We have learned about the final results of important clinical trials across multiple genitourinary cancers disease states leading to...
Physicians, New Drugs, and Pharma
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have approved record numbers of new cancer drugs recently. This is extraordinarily good news for physicians, patients, and drug companies, but it raises important questions as to how effective these drugs are, whether...
Pembrolizumab for Cutaneous Squamous Cell Carcinoma
On June 24, 2020, pembrolizumab was approved for treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.1,2 Supporting Efficacy Data Approval was based on findings in the multicenter, multicohort, open-label KEYNOTE-629 trial ...
Pembrolizumab for First-Line Treatment of Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer
On June 29, 2020, pembrolizumab was approved for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer.1 Supporting Efficacy Data Approval was based on findings in the randomized,...
Gemtuzumab Ozogamicin in Pediatric Patients With Newly Diagnosed CD33-Positive AML
On June 16, 2020, the indication of gemtuzumab ozogamicin (Mylotarg) for newly diagnosed CD33-positive acute myeloid leukemia (AML) was extended to include pediatric patients aged 1 month and older.1,2 Supporting Efficacy Data Approval was supported by findings from the phase III AAML0531 trial...
Selinexor in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
On June 22, 2020, the oral nuclear export inhibitor selinexor was granted accelerated approval for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic...
Fixed-Dose Subcutaneous Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf in HER2-Positive Breast Cancer
On June 29, 2020, a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) for subcutaneous injection was approved for the following indications1,2: Use in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced,...
Highlights of Research in Lymphomas Presented During the EHA25 Virtual Congress
To complement The ASCO Post’s continued coverage of the virtual edition of the 25th European Hematology Association Annual Congress (EHA25 Virtual), here are a few abstracts selected from the meeting proceedings focusing on clinical research in Hodgkin and marginal zone lymphomas. Omission of...
Tazemetostat for Adults With Relapsed or Refractory Follicular Lymphoma
On June 18, 2020, the EZH2 inhibitor tazemetostat was granted accelerated approval for the treatment of adults with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test, and who have...
NCCN Clinical Practice Guidelines in Oncology: 2020 Updates
In 1996, the National Comprehensive Cancer Network (NCCN) published its first set of Clinical Practice Guidelines in Oncology®, covering eight tumor types. Guidelines are now published for more than 60 tumor types and topics. During the NCCN’s 25th Annual Conference, which was held virtually during ...
Novel Treatments Emerge for Patients With Lower-Risk Myelodysplastic Syndromes
Patients with lower-risk myelodysplastic syndromes (MDS) who are dependent on red blood cell transfusions have limited options, especially if they are no longer responding to erythropoiesis-stimulating agents. Research presented during the virtual edition of the 25th European Hematology Association ...
FDA Pipeline: Designations in Kidney and Lung Cancers, Myelodysplastic Syndromes, and More
Over the past few weeks, the U.S. Food and Drug Administration (FDA) has issued designations and accepted applications for novel agents, as well as approved companion diagnostics. We summarize these regulatory movements below. Breakthrough Therapy Designation for MK-6482 in von Hippel-Lindau...
FDA Grants Accelerated Approval to Belantamab Mafodotin-blmf for Pretreated Patients With Relapsed or Refractory Multiple Myeloma
On August 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to belantamab mafodotin-blmf (Blenrep), an anti-B-cell maturation antigen antibody-drug conjugate, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies,...
FDA Approves Tafasitamab-cxix Combined With Lenalidomide to Treat Adults With Relapsed/Refractory DLBCL
On July 31, the U.S. Food and Drug Administration (FDA) approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)–not otherwise specified, including DLBCL arising from low-grade...
FDA Approves Atezolizumab Plus Cobimetinib/Vemurafenib for Advanced BRAF V600–Mutated Melanoma
On July 30, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhibitor atezolizumab (Tecentriq) plus the MEK inhibitor cobimetinib (Cotellic) and the selective BRAF kinase inhibitor vemurafenib (Zelboraf) for the treatment of patients with advanced BRAF V600 mutation–positive...
FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma
On July 24, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brexucabtagene autoleucel (Tecartus), a CD19-directed genetically modified autologous T-cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. “Tremendous...
Lurbinectedin in Previously Treated Metastatic Small Cell Lung Cancer
On June 15, 2020, the alkylating drug lurbinectedin was granted accelerated approval for treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression during or after platinum-based chemotherapy.1,2 Supporting Efficacy Data Accelerated approval was based on...
Nivolumab in Previously Treated Esophageal Squamous Cell Carcinoma
On June 10, 2020, nivolumab was approved for treatment of patients with unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings from the open-label,...
Pembrolizumab for Adult and Pediatric Patients With Tumor Mutational Burden–High Solid Tumors
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On June 16, 2020, pembrolizumab was granted accelerated...
In Case You Missed It: Quick Takes on Novel Therapies for Solid and Hematologic Malignancies
Because of the COVID-19 pandemic, oncology providers from around the world had to forgo their annual trip to McCormick Place—but the show did go on. We all realized important research can still be presented, clinicians and fellow researchers will still listen, and ASCO presentations will still...
Monumental Progress in the Treatment of Diffuse Large B-Cell Lymphoma
Some monuments are difficult to topple. At least that was the case dating back to 1976, when investigators from the Southwest Oncology Group demonstrated the importance of doxorubicin in the treatment of patients with a group of lymphoid malignancies then referred to as diffuse aggressive...
FDA Pipeline: Novel Treatments for Hematologic Malignancies
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to pembrolizumab for the second-line treatment of patients with relapsed or refractory Hodgkin lymphoma, and also accepted a supplemental new drug application for selinexor for pretreated patients with multiple myeloma....
Atezolizumab as First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression and No EGFR or ALK Aberrations
On May 18, 2020, atezolizumab was approved for the first-line treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations. High PD-L1 expression is defined as PD-L1 staining of at least 50% of...
Elderberry
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Yen Nien Hou, PharmD, DiplOM, LAc, and Jyothirmai Gubili, MS, focus on...
New Recommendations Offer Guidance for Clinicians and Patients on Genetic Testing for Prostate Cancer
An international panel of experts led by researchers and thought leaders at the Sidney Kimmel Cancer Center–Jefferson Health (SKCC) and the Department of Urology at Jefferson have published the first multidisciplinary, consensus-driven, prostate cancer genetic implementation framework for the...
The 21st Century Cures Act: A Look Back, a Look Ahead
It was ambitious and it was controversial, but the bipartisan 21st Century Cures Act (Cures) made it through both houses of Congress and was signed into law in December 2016. Sponsored by Representatives Diana DeGette (D-CO) and Fred Upton (R-MI), the landmark legislation funded new medical...
Atezolizumab Plus Bevacizumab for Unresectable or Metastatic Hepatocellular Carcinoma
On May 29, 2020, atezolizumab in combination with bevacizumab was approved for treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.1-3 Supporting Efficacy Data Approval was based on findings in the international, open-label,...
FDA Collaborating on Use of Real-World Data to Inform COVID-19 Response Effort
On June 18, 2020, the U.S. Food and Drug Administration (FDA) took an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency. The FDA announced its participation in the COVID-19 Diagnostics Evidence Accelerator, a...
Rucaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
On May 15, 2020, rucaparib was granted accelerated approval for the treatment of patients with deleterious BRCA mutation–associated (germline or somatic) metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy and taxane-based chemotherapy.1,2...
Nivolumab Plus Ipilimumab in Two New Lung Cancer Indications
The combination of nivolumab and ipilimumab was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with non–small cell lung cancer (NSCLC) in two different regimens: On May 15, 2020, the two-drug combination was approved for first-line treatment in...
Daratumumab and Hyaluronidase-fihj for Multiple Myeloma
On May 1, 2020, the combination of daratumumab and hyaluronidase-fihj was approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous (SC) dosing of daratumumab.1,2 Daratumumab and hyaluronidase-fihj is for SC use only. The...
FDA Approves Oral Combination of Decitabine and Cedazuridine for Adult Patients With Myelodysplastic Syndromes
On July 7, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (Inqovi) for adult patients with myelodysplastic syndromes (MDS), including the following: Previously treated and untreated de novo and secondary MDS with the following...
Longer-Term Results of Pivotal Study in Advanced Cutaneous Squamous Cell Carcinoma
New, longer-term data from a pivotal phase II trial in advanced cutaneous squamous cell carcinoma (CSCC), were presented during the ASCO20 Virtual Scientific Program and discussed during a poster discussion.1 Danny Rischin, MD, of the Peter MacCallum Cancer Centre, Victoria, Australia, presented...
Expert Point of View: Scott N. Gettinger, MD
Discussant for the CheckMate 227 and CheckMate 9LA trials, Scott N. Gettinger, MD, of Yale Cancer Center in New Haven, Connecticut, said: “There is tremendous interest in lung cancer to combine nivolumab plus ipilimumab, driven by the melanoma experience. However, combinations of immunotherapy come ...
First-Line Nivolumab Plus Ipilimumab Shows Activity in NSCLC, With or Without Chemotherapy
Advanced non–small cell lung cancer (NSCLC) in patients whose tumors have no EGFR or ALK alterations poses a particular challenge in terms of first-line therapy. The use of nivolumab plus ipilimumab as well as nivolumab/ipilimumab plus two cycles of chemotherapy, respectively, as first-line therapy ...
